Feasibility of a Smartphone Application for Asthma Self-management

University of South Florida

Status: Enrolling

Conditions: Asthma Chronic

Treatments: Device: Asthma SMART

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05572177

R34HL145442 (U.S. NIH Grant/Contract)

STUDY000956

Details and patient eligibility

About

The primary goal of this project is to determine the feasibility, acceptability, and adherence of a smartphone application for improving asthma self-management in a pilot randomized controlled trial (RCT). The app is specifically designed to appeal to adolescents. Adolescents with persistent asthma will be randomized to receive: 1) standard-of-care or 2) the self-management app in addition to standard-of-care. Feasibility will be assessed by the ability to recruit and retain subjects, technical barriers to implementation, and the appropriateness of the intervention among adolescents and providers. The acceptability of the intervention will be determined by appraising perceived usefulness, entertainment, and ease of use of the app. Adherence to usage of the app over a 6-month period will be assessed by examining the frequency of app usage and the features that were used, and the extent of data regarding self-management that was entered. A secondary objective is to obtain preliminary estimates of effectiveness of the app on clinical outcomes (ACT score, spirometry, CHSA-C, exacerbations, and medication adherence) relative to standard-of-care. It is hypothesized that the app will result in a high level of adherence and will be a feasible and acceptable intervention to improve self-management among adolescents with persistent asthma.

Enrollment: 50 estimated patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 12 and less than 18 years at enrollment
• Established mild, moderate, or severe persistent asthma with a diagnosis verified by clinic physicians
• Speak English
• Not planning on moving out of the Tampa Bay area during the trial period
• Must have a suitable iPhone or Android device available to use with the app

Exclusion criteria

• Having mental or other development disorder that may make self-management of a chronic condition difficult
• Having other chronic lung disease or one or more of the following disorders including cystic fibrosis, neuromuscular disease, immunodeficiency or autoimmune disorders, blindness or severe vision impairment that may interfere with the ability to use the mobile app
• Having participated in the app development phase of the funded project

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Asthma SMART

Experimental group

Description:

Subjects randomized to the intervention arm will be provided with the app to download to their personal iPhone or Android smartphone. Subjects will be asked to use the app every day for 6 months.

Treatment:

Device: Asthma SMART

Standard of care

No Intervention group

Description:

Subjects randomized to the standard-of-care arm will continue to receive regular care for their condition.